Cleared Traditional

K072268 - HC WBC HEMATOLOGY CONTROL

K072268 is the FDA 510(k) clearance for HC WBC HEMATOLOGY CONTROL by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K072268 · R&D Systems, Inc. · Hematology device
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Nov 2007
Decision
97d
Days
Class 2
Risk

K072268 is an FDA 510(k) clearance for the HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 20, 2007 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all R&D Systems, Inc. devices

Submission Details

510(k) Number K072268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2007
Decision Date November 20, 2007
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K072268.
COULTER LIN-X LINEARITY CONTROL
K081641 · Beckman Coulter, Inc. · Jan 2009
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K073178 · R&D Systems, Inc. · Dec 2007
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · R&D Systems, Inc. · Nov 2007
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K072096 · R&D Systems, Inc. · Aug 2007
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · R&D Systems, Inc. · Jul 2006
R&D LH-NRBC HEMATOLOGY CONTROL
K061320 · R&D Systems, Inc. · Jun 2006